The Lynx Group

April 2021, Vol 12, No 2

On February 26, 2021, the FDA accelerated the approval of melphalan flufenamide (Pepaxto; Oncopeptides AB), an alkylating drug, for the treatment, in combination with dexamethasone, of adults with relapsed or refractory multiple myeloma who have received ≥4 lines of therapy and whose disease is triple-refractory to ≥1 proteasome inhibitors, 1 immunomodulatory drug, and 1 CD-38–directed monoclonal antibody.
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On February 12, 2021, the FDA approved trilaciclib (Cosela; G1 Therapeutics), as a first-in-class cyclin-dependent kinase (CDK)4/6 inhibitor to reduce the frequency of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer, when used before a platinum plus etoposide regimen or a topotecan-containing regimen. Trilaciclib may prevent damage to bone marrow cells by inhibiting the CDK4/6 enzyme. The FDA granted trilaciclib priority review and a breakthrough therapy designation.
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On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after ≥2 previous lines of systemic therapy. The FDA granted lisocabtagene maraleucel priority review, as well as breakthrough therapy, orphan drug, and regenerative medicine advanced therapy designations.
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On February 5, 2021, the FDA approved umbralisib (Ukoniq; TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma (FL). Umbralisib is indicated for MZL after ≥1 CD20-directed regimens, and for FL after ≥3 lines of systemic therapy.
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On March 30, 2021, the FDA approved a new indication for daunorubicin and cytarabine (Vyxeos; Jazz Pharmaceuticals) for the treatment of pediatric patients aged ≥1 years with newly diagnosed, therapy-related acute myeloid leukemia (AML) or patients with AML and myelodysplasia-related changes. Daunorubicin and cytarabine is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine).
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On March 5, 2021, the FDA approved a new indication for axicabtagene ciloleucel (Yescarta; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received ≥2 lines of systemic therapy. The FDA granted this indication a priority review as well as breakthrough therapy and orphan drug designations.
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On March 3, 2021, the FDA approved a new indication for lorlatinib (Lorbrena; Pfizer), a third-generation ALK inhibitor, for the first-line treatment of patients with non–small-cell lung cancer (NSCLC) and ALK mutation.
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On February 9, 2021, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron/sanofi-aventis) for the treatment of locally advanced or metastatic basal-cell carcinoma (BCC) in patients who had received or are ineligible to receive a hedgehog inhibitor. The FDA granted cemiplimab a priority review and accelerated its approval for this indication.
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Sacituzumab govitecan (Trodelvy) led to increased response rates and improved progression-free survival (PFS) compared with chemotherapy in heavily pretreated patients with metastatic triple-negative breast cancer (TNBC) and stable brain metastases, according to a subgroup analysis of the phase 3 ASCENT clinical trial. The drug did not lead to improved overall survival (OS) in patients with stable brain metastases. These results were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS).
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Pembrolizumab (Keytruda) plus chemotherapy improved progression-free survival (PFS) compared with chemotherapy alone as first-line treatment of metastatic triple-negative breast cancer (TNBC), according to the results of KEYNOTE-355. Improvement in PFS with the addition of pembrolizumab to chemotherapy was more robust in patients with TNBC and PD-L1 expression. These results from KEYNOTE-355 were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) and add to a growing body of evidence supporting the first-line use of pembrolizumab plus chemotherapy combinations for TNBC.
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